Novel Pertussis Vaccines: Challenge Models ‘Promising’ But Need More Work

 
• By Michael McCaughan

A US FDA Advisory Committee responded enthusiastically to the potential use of challenge models to enable pivotal trials of novel pertussis vaccines, but most members suggested more refinements are needed before they are ready to use.

A company wants to initiate a pertusis vaccine trial using a human challenge model, but the FDA is unsure of the idea. (Shutterstock)
Michael McCaughan

Read more by Michael McCaughan

Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.

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